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IACUC Policy 003: Semiannual Program Review

  1. Purpose: The IACUC is committed to conducting thorough and timely semiannual program evaluations to maintain high standards of animal care and use. These evaluations will be conducted in accordance with federal regulations, PHS Policy, the Animal Welfare Act, as well as the Guide for the Care and Use of Laboratory Animals, and in accordance with Ohio University policy and procedure(s).

  1. Scope: This policy applies to all semiannual program evaluations, including programmatic reviews and inspections of all animal housing facilities.

  1. Policy Statement: The IACUC is committed to conducting thorough and timely semiannual program evaluations to maintain high standards of animal care and use. These evaluations will be conducted in accordance with federal regulations and institutional guidelines. 

     

  2. Key Elements: Who, What, When, and Where?

Who

At least two IACUC members must be present for the inspection (10.1).

NOTE: No member wishing to participate in an evaluation may be excluded from participating (10.2). 

What

The documents to be included in the Program Evaluation include, but are not limited to:

  • Review of the Facility Inspection Report & Assignment of Corrective Actions & Due Date
  • Review of the Animal Care and Use Program Description.
  • Review of IACUC Policies, Procedures, and Guidelines
  • Review of the Disaster & Emergency Preparedness Plan  
When

While the inspection of each facility must occur semiannually, there is no regulatory requirement that all facilities at an institution must be inspected at the same time (e.g., during the same month) (10.3). Therefore, the IACUC may elect to stagger these inspections throughout the year, as long as each animal area is inspected at least every six months (10.3).

  • At OHIO, semiannual program evaluations typically begin in May and November with the semiannual facility inspection occurring first.
  • The review of the facility inspection report and the assignment of corrective actions should occur no less than two weeks following the inspection, typically at the program review meeting.
  • Review of program documents should occur no more than two weeks from the date of the facility inspection. The committee strives to include as many members as possible in the program review.
  • The Semiannual Letter to the IO is submitted for review no more than two weeks following the Program Evaluation meeting. 
Where

All animal housing facilities must be inspected in the semiannual evaluation, including (5.1): 

  • satellite facilities (containment areas outside the central/core animal facility where animals are housed for more than 24 hours (PHS Policy)
  • areas in which surgical manipulations are performed (PHS Policy)
  • animal study areas (locations where USDA-covered species are held for more than 12 hours) (AWRs)
  • holding facilities (AWRs).

* Laboratories in which routine procedures, such as immunization, dosing, and weighing, are conducted may be evaluated by other means such as random inspections or be included in the semiannual program evaluation. The IACUC evaluates these areas for the purpose of verifying that activities involving animals are being conducted in accordance with the approved protocol. 

  1. Corrective Actions:

  • For minor deficiencies, failure to complete the assigned corrective action(s) will be brought to the attention of IACUC. For extenuating circumstances, the IACUC may elect to extend the due date of the corrective action(s). In some cases, the IACUC may elect to notify the Intuitional Official (IO) for further guidance on how to proceed.
  • For significant deficiencies, failure to adhere to the corrective action plan will be brought to the attention of the Intuitional Official (IO). The applicable reporting mechanisms described in IACUC Procedure ___: Semiannual Program Review will be followed. 

  1. Communication:

  • The IACUC may elect to elect to conduct announced or unannounced facility inspections. However, the IACUC generally prefers to announce inspections. For announced inspections, the expectation is that the PI or person responsible for the location is available and present to open drug boxes, provide documentation, or answer questions. 
  • For PI’s with controlled substance drug boxes, the IACUC will work with the PI to ensure that a lab representative is present at the time of the inspection to allow the IACUC to inspect the drug box.
  • The Office of Research Compliance is responsible for communicating a description of the deficiencies observed, the corrective actions and due date in writing to the Principal Investigator (PI) or party responsible for the area.

  1. Semiannual Reports to the IO:

  • A written report of the semiannual program review and facility inspection is submitted to an Institutional Official (IO) within two weeks of completing the evaluation. 

  1. Record Retention: 

  • A copy of the report is sent to the IO and must be kept on file for a minimum of three years.

  1. Definitions & Acronyms:

  • PHS- Public Health Service
  • AWRs- Animal Welfare Regulations
  • IO- Institutional Official

  1. References & Resources:

        10.1 Guidance on Flexibilities for Conducting Semiannual Inspections of Animal Facilities https://grants.nih.gov/grants/guide/notice-files/NOT-OD-24-075.html

       10.2 Semiannual Program Reviews and Facility Inspections- https://olaw.nih.gov/resources/tutorial/iacuc.htm

       10.3 Institutional Animal Care and Use Committee Guidebook (pg. 154, 171-173)-https://olaw.nih.gov/sites/default/files/GuideBook.pdf 

  1. Change History: 

Version Number:

Details of Change:

Approval Date:

1.0

This is a new IACUC policy.

10/04/2024